U.S. patent application number 15/951931 was filed with the patent office on 2018-08-16 for catheter placement device including guidewire and catheter control elements.
The applicant listed for this patent is C. R. Bard, Inc.. Invention is credited to Daniel B. Blanchard, Jay A. Muse, Rex A. Ribelin, Matthew C. Rich, Thomas S. Russell, Andrew C. Sheffield, Joshua D. Sherwood, Jason R. Stats.
Application Number | 20180229003 15/951931 |
Document ID | / |
Family ID | 53797155 |
Filed Date | 2018-08-16 |
United States Patent
Application |
20180229003 |
Kind Code |
A1 |
Blanchard; Daniel B. ; et
al. |
August 16, 2018 |
Catheter Placement Device Including Guidewire and Catheter Control
Elements
Abstract
An insertion tool for inserting a catheter into a patient's body
is disclosed. The insertion tool unifies needle insertion,
guidewire advancement, and catheter insertion in a single device.
In one embodiment, the insertion tool comprises a housing in which
at least a portion of the catheter is initially disposed, a hollow
needle distally extending from the housing with at least a portion
of the catheter pre-disposed over the needle, and a guidewire
pre-disposed within the needle. A guidewire advancement assembly is
also included for selectively advancing the guidewire distally past
a distal end of the needle in preparation for distal advancement of
the catheter. In one embodiment a catheter advancement assembly is
also included for selectively advancing the catheter into the
patient. Each advancement assembly can include a slide or other
actuator that enables a user to selectively advance the desired
component. Guidewire and catheter locking systems are also
disclosed.
Inventors: |
Blanchard; Daniel B.;
(Bountiful, UT) ; Ribelin; Rex A.; (West Jordan,
UT) ; Russell; Thomas S.; (Sandy, UT) ; Stats;
Jason R.; (Layton, UT) ; Sherwood; Joshua D.;
(Cottonwood Heights, UT) ; Muse; Jay A.; (Salt
Lake City, UT) ; Sheffield; Andrew C.; (Kaysville,
UT) ; Rich; Matthew C.; (St. George, UT) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
C. R. Bard, Inc. |
Murray Hill |
NJ |
US |
|
|
Family ID: |
53797155 |
Appl. No.: |
15/951931 |
Filed: |
April 12, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14702580 |
May 1, 2015 |
9950139 |
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15951931 |
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14099050 |
Dec 6, 2013 |
9872971 |
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14702580 |
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|
13107781 |
May 13, 2011 |
8932258 |
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14099050 |
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61988114 |
May 2, 2014 |
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61771703 |
Mar 1, 2013 |
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61385844 |
Sep 23, 2010 |
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61372050 |
Aug 9, 2010 |
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61345005 |
May 14, 2010 |
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61345022 |
May 14, 2010 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 25/065 20130101;
A61M 25/0618 20130101; A61M 25/0097 20130101; A61M 25/09041
20130101; A61M 25/0105 20130101 |
International
Class: |
A61M 25/00 20060101
A61M025/00; A61M 25/06 20060101 A61M025/06; A61M 25/09 20060101
A61M025/09; A61M 25/01 20060101 A61M025/01 |
Claims
1. An insertion tool for inserting a catheter into a body of a
patient, comprising: a housing; a needle distally extending from
the housing, the catheter pre-disposed over the needle; and a
guidewire having a distal end pre-disposed in a lumen of the
needle, the catheter including: a catheter hub pre-disposed in the
housing; a catheter tube extending from the catheter hub, the
catheter tube including a first material from a proximal end to a
distal tip; and a reinforcement component included in the distal
tip of the catheter tube, the reinforcement component including a
second material more rigid than the first material.
2. The insertion tool according to claim 1, wherein the
reinforcement component comprises an annular sleeve defining at
least a portion of a lumen in the distal tip of the catheter
tube.
3. The insertion tool according to claim 1, wherein the second
material is non-softening at an internal body temperature.
4. The insertion tool according to claim 3, wherein the second
material has a melt temperature similar to a melt temperature of
the first material.
5. The insertion tool according to claim 1, wherein the second
material is selected from the group consisting of aromatic
polyurethane, carbothane, isoplast, pebax, nylon, stainless steel,
titanium, nitinol, and combinations thereof.
6. The insertion tool according to claim 1, wherein the
reinforcement component includes a radiopacifier selected from the
group consisting of bismuth trioxide, barium sulfate, and
combinations thereof.
7. The insertion tool according to claim 1, wherein the
reinforcement component defines a distal opening in the distal tip
of the catheter tube.
8. The insertion tool according to claim 1, further comprising a
guidewire advancement assembly designed to distally advance the
distal end of the guidewire out of a distal opening of the
needle.
9. The insertion tool according to claim 8, further comprising a
catheter advancement assembly designed to distally advance the
catheter, the catheter advancement assembly including a proximal
portion in locking engagement with the housing when the guidewire
advancement assembly is in a guidewire retracted position, the
guidewire advancement assembly including an actuation member
designed to disengage the proximal portion in a guidewire advanced
position.
10. The insertion tool according to claim 9, wherein the guidewire
advancement assembly includes a locking member to prevent proximal
retraction of the guidewire after the catheter advancement assembly
has been distally advanced from a catheter retracted position.
11. The insertion tool according to claim 10, wherein the proximal
portion of the catheter advancement assembly is in locking
engagement with a needle hub in the guidewire retracted position,
the actuation member of the guidewire advancement assembly
disengaging the proximal portion from the needle hub in the
guidewire advanced position.
12. The insertion tool according to claim 9, wherein the catheter
advancement assembly includes a handle assembly having a head
portion and a tail portion removably attached to the catheter, the
tail portion including the proximal portion.
13. The insertion tool according to claim 12, wherein the catheter
includes a catheter hub, the handle assembly removably attached to
the catheter hub, wherein a valve is removably included in the
catheter hub, and wherein a safety housing is removably disposed in
the valve.
14. The insertion tool according to claim 12, wherein the handle
assembly includes a living hinge to enable the handle assembly to
be removed from the catheter hub.
15. The insertion tool according to claim 1, wherein the housing
includes: a top housing portion; a bottom housing portion; and a
stability structure having a top portion included with the top
housing portion and a bottom portion included with the bottom
housing portion, wherein: the bottom portion of the stability
structure is configured to be substantially flexible in a first
direction and substantially rigid in a second direction, and the
top portion of the stability structure is configured to be
substantially flexible in the second direction and substantially
rigid in the first direction.
16. The insertion tool according to claim 15, wherein the top
portion and the bottom portion of the stability structure overlap
one another.
17. The insertion tool according to claim 15, wherein the bottom
portion of the stability structure includes a first arm designed to
spread apart from a second arm to enable the catheter to pass out
of the housing.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a division of U.S. patent application
Ser. No. 14/702,580, filed May 1, 2015, now U.S. Pat. No.
9,950,139, which claims the benefit of U.S. Provisional Patent
Application No. 61/988,114, filed May 2, 2014, and titled "Catheter
Placement Device Including Catheter and Guidewire Control Systems,"
and which is a continuation-in-part of U.S. patent application Ser.
No. 14/099,050, filed Dec. 6, 2013, now U.S. Pat. No. 9,872,971,
and titled "Guidewire Extension System for a Catheter Placement
Device, which claims the benefit of U.S. Provisional Patent
Application No. 61/771,703, filed Mar. 1, 2013, and titled "Needle
Safety and Guidewire Extension Systems for a Catheter Insertion
Device," and which is a continuation-in-part of U.S. patent
application Ser. No. 13/107,781, filed May 13, 2011, now U.S. Pat.
No. 8,932,258, and titled "Catheter Placement Device and Method,"
which claims the benefit of the following U.S. Provisional Patent
Application Nos. 61/345,005, filed May 14, 2010, and titled
"Catheter Insertion System Including an Integrated Guidewire
Dilator;" 61/345,022, filed May 14, 2010, and titled "Systems and
Methods for Placement of an Intermediate Dwell Catheter Including a
Needle Blunting System;" 61/372,050, filed Aug. 9, 2010, and titled
"Catheter Insertion Tool Including Fold-out Guidewire Advancement
Flaps;" and 61/385,844, filed Sep. 23, 2010, and titled "Catheter
Insertion Tool Including Guidewire Advancement." Each of the
aforementioned applications is incorporated herein by reference in
its entirety.
BRIEF SUMMARY
[0002] Briefly summarized, embodiments of the present invention are
directed to an insertion tool for inserting a catheter or other
tubular medical device into a body of a patient. The insertion tool
in one embodiment unifies needle insertion, guidewire advancement,
and catheter insertion in a single device to provide for a simple
catheter placement procedure.
[0003] In one embodiment, the insertion tool comprises a housing in
which at least a portion of the catheter is initially disposed, a
hollow needle distally extending from the housing with at least a
portion of the catheter pre-disposed over the needle, and a
guidewire pre-disposed within the needle. An advancement assembly
is also included for selectively advancing the guidewire distally
past a distal end of the needle in preparation for distal
advancement of the catheter. In one embodiment a catheter
advancement assembly is also included for selectively advancing the
catheter into the patient. Each advancement assembly can include a
slide or other actuator that enables a user to selectively advance
the desired component.
[0004] In one embodiment the catheter advancement assembly further
includes a handle that is initially and removably attached to a hub
of the catheter within the housing. Distal movement of handle by a
user in turn distally moves the catheter distally from the housing.
The handle can include a needle safety component for isolating a
distal tip of the needle when the needle is removed from the
catheter and the distal tip received into the handle. In addition,
various guidewire and catheter advancement assemblies are disclosed
herein.
[0005] In yet another embodiment, various features are included
with the insertion tool, including: actuation of the guidewire and
catheter advancement assemblies without moving the hand of the user
that grasps the insertion tool during the catheter insertion
procedure; selective advancement of one of the guidewire or
catheter based upon previous advancement of the other; and
guidewire blunting features.
[0006] These and other features of embodiments of the present
invention will become more fully apparent from the following
description and appended claims, or may be learned by the practice
of embodiments of the invention as set forth hereinafter.
BRIEF DESCRIPTION OF THE DRAWINGS
[0007] A more particular description of the present disclosure will
be rendered by reference to specific embodiments thereof that are
illustrated in the appended drawings. It is appreciated that these
drawings depict only typical embodiments of the invention and are
therefore not to be considered limiting of its scope. Example
embodiments of the invention will be described and explained with
additional specificity and detail through the use of the
accompanying drawings in which:
[0008] FIGS. 1A and 1B are various views of a catheter insertion
device according to one embodiment;
[0009] FIGS. 2A and 2B are various exploded views of the catheter
insertion device of FIGS. 1A and 1B;
[0010] FIGS. 3A and 3B show various views of one stage of use of
the catheter insertion tool of FIGS. 1A and 1B according to one
embodiment;
[0011] FIGS. 4A and 4B show various views of one stage of use of
the catheter insertion tool of FIGS. 1A and 1B according to one
embodiment;
[0012] FIGS. 5A and 5B show various views of one stage of use of
the catheter insertion tool of FIGS. 1A and 1B according to one
embodiment;
[0013] FIGS. 6A and 6B show various views of one stage of use of
the catheter insertion tool of FIGS. 1A and 1B according to one
embodiment;
[0014] FIGS. 7A and 7B show various views of one stage of use of
the catheter insertion tool of FIGS. 1A and 1B according to one
embodiment;
[0015] FIG. 8 shows one stage of use of the catheter insertion tool
of FIGS. 1A and 1B according to one embodiment;
[0016] FIG. 9 shows one stage of use of the catheter insertion tool
of FIGS. 1A and 1B according to one embodiment;
[0017] FIGS. 10A-10C shows various views of a needle safety
component and environment for a catheter insertion tool, according
to one embodiment;
[0018] FIGS. 11A-11D are various views of a catheter insertion
device according to one embodiment;
[0019] FIGS. 12A and 12B are various views of a portion of the
catheter insertion device of FIGS. 11A-11D;
[0020] FIGS. 13A and 13B are various views of a portion of the
catheter insertion device of FIGS. 11A-11D;
[0021] FIGS. 14A-14F show various stages of use of the catheter
insertion tool of FIGS. 11A-11D according to one embodiment;
[0022] FIGS. 15A and 15B are various views of a catheter insertion
device according to one embodiment;
[0023] FIG. 16 is a cross sectional side view of an integrated
guidewire/dilator for use with the catheter insertion device of
FIGS. 15A and 15B;
[0024] FIGS. 17A-17C are various views of a slotted needle for use
with the catheter insertion device of FIGS. 15A and 15B according
to one embodiment;
[0025] FIG. 18 is a cross sectional side view of a portion of the
catheter insertion device of FIGS. 15A and 15B;
[0026] FIG. 19 shows one stage of use of the catheter insertion
tool of FIGS. 15A and 15B according to one embodiment;
[0027] FIGS. 20A and 20B show one stage of use of the catheter
insertion tool of FIGS. 15A and 15B according to one
embodiment;
[0028] FIGS. 21A and 21B show one stage of use of the catheter
insertion tool of FIGS. 15A and 15B according to one
embodiment;
[0029] FIG. 22 shows one stage of use of the catheter insertion
tool of FIGS. 15A and 15B according to one embodiment;
[0030] FIG. 23 shows one stage of use of the catheter insertion
tool of FIGS. 15A and 15B according to one embodiment;
[0031] FIG. 24 shows one stage of use of the catheter insertion
tool of FIGS. 15A and 15B according to one embodiment;
[0032] FIGS. 25A and 25B shows various views of a needle distal tip
and guidewire blunting design according to one embodiment;
[0033] FIG. 26 is a perspective view of a needle distal tip design
according to one embodiment;
[0034] FIG. 27 is a perspective view of a catheter insertion tool
according to one embodiment;
[0035] FIG. 28 is a cross sectional view of a catheter insertion
tool according to one embodiment;
[0036] FIGS. 29A and 29B are various views of a catheter insertion
tool according to one embodiment;
[0037] FIG. 30 is a perspective view of a catheter insertion tool
according to one embodiment;
[0038] FIG. 31 is a perspective view of a catheter insertion tool
according to one embodiment;
[0039] FIGS. 32A-32I are various views of a configuration of a
catheter insertion tool during use, according to one
embodiment;
[0040] FIGS. 33A-33C are various views of a safety needle component
according to one embodiment;
[0041] FIG. 34 is an exploded view of a catheter insertion device
according to one embodiment;
[0042] FIG. 35 is a perspective view of a portion of a guidewire
lever according to one embodiment;
[0043] FIGS. 36A and 36B are cutaway views of a proximal portion of
the catheter insertion device of FIG. 34;
[0044] FIG. 37 is a perspective view of a proximal portion of the
top housing portion of the catheter insertion device of FIG.
34;
[0045] FIG. 38 is a cutaway view of a proximal portion of the
catheter insertion device of FIG. 34;
[0046] FIGS. 39A and 39B are various views of a needle safety
component according to one embodiment;
[0047] FIGS. 40A-40D are various views of the needle safety
component of FIGS. 39A and 39B and an accompanying carriage;
[0048] FIGS. 41A and 41B are cutaway views of a proximal portion of
the catheter insertion device of FIG. 34;
[0049] FIG. 42 is a cross-sectional view of a guidewire for use
with a catheter insertion tool according to one embodiment;
[0050] FIG. 43 is a side view of the guidewire of FIG. 42 partially
disposed within a needle;
[0051] FIG. 44 is a cross-sectional view of a distal portion of a
catheter tube including a reinforcement component according to one
embodiment;
[0052] FIGS. 45A and 45B show various stages of manufacture of the
catheter tube of FIG. 44;
[0053] FIG. 46 is a cross-sectional view of a distal portion of a
catheter tube including a reinforcement component according to one
embodiment;
[0054] FIGS. 47A and 47B show cross-sectional views of distal
portions of catheter tubes including a reinforcement component
according to additional embodiments;
[0055] FIGS. 48A-48F are various views of a catheter insertion tool
according to one embodiment;
[0056] FIG. 49 is an exploded view of the insertion tool of FIGS.
48A-48F;
[0057] FIGS. 50A and 50B show various views of the insertion tool
of FIGS. 48A-48F;
[0058] FIG. 51 is a top view of a guidewire advancement assembly
and a catheter advancement assembly of FIGS. 48A-48F;
[0059] FIG. 52 is a perspective view of the guidewire advancement
assembly of the insertion tool of FIGS. 48A-48F;
[0060] FIGS. 53A-53B show details of the operation of the guidewire
advancement assembly of FIG. 52;
[0061] FIG. 54 is a perspective view of the insertion tool of FIGS.
48A-48F in one state;
[0062] FIG. 55 is a top view of the guidewire advancement assembly
of FIG. 52;
[0063] FIG. 56A-56C are various views of a portion of a catheter
advancement assembly of the insertion tool of FIGS. 48A-48F;
[0064] FIGS. 57A and 57B are various views of the distal portion of
the insertion tool of FIGS. 48A-48F;
[0065] FIGS. 58 and 59 shows various views of the catheter
advancement assembly of the insertion tool of FIGS. 48A-48F;
[0066] FIG. 60 is a perspective view of the catheter advancement
assembly of the insertion tool of FIGS. 48A-48F;
[0067] FIG. 61 is a perspective view of a handle of a catheter
advancement assembly according to one embodiment;
[0068] FIG. 62 is a side view of the handle of FIG. 61;
[0069] FIG. 63 is a perspective view of a handle of a catheter
advancement assembly according to one embodiment;
[0070] FIG. 64 is a perspective view of a handle of a catheter
advancement assembly according to one embodiment;
[0071] FIG. 65 is a side view of the handle of FIG. 64; and
[0072] FIGS. 66A-66C are various views of an insertion tool
according to one embodiment.
DETAILED DESCRIPTION OF SELECTED EMBODIMENTS
[0073] Reference will now be made to figures wherein like
structures will be provided with like reference designations. It is
understood that the drawings are diagrammatic and schematic
representations of exemplary embodiments of the present invention,
and are neither limiting nor necessarily drawn to scale.
[0074] For clarity it is to be understood that the word "proximal"
refers to a direction relatively closer to a clinician using the
device to be described herein, while the word "distal" refers to a
direction relatively further from the clinician. For example, the
end of a catheter placed within the body of a patient is considered
a distal end of the catheter, while the catheter end remaining
outside the body is a proximal end of the catheter. Also, the words
"including," "has," and "having," as used herein, including the
claims, shall have the same meaning as the word "comprising."
[0075] Embodiments of the present invention are generally directed
to a tool for assisting with the placement into a patient of a
catheter or other tubular medical device. For example, catheters of
various lengths are typically placed into a body of a patient so as
to establish access to the patient's vasculature and enable the
infusion of medicaments or aspiration of body fluids. The catheter
insertion tool to be described herein facilitates such catheter
placement. Note that, while the discussion below focuses on the
placement of catheters of a particular type and relatively short
length, catheters of a variety of types, sizes, and lengths can be
inserted via the present device, including peripheral IV's
intermediate or extended-dwell catheters, PICC's, central venous
catheters, etc. In one embodiment, catheters having a length
between about 2.5 inches and about 4.5 inches can be placed, though
many other lengths are also possible. In another embodiment a
catheter having a length of about 3.25 inches can be placed.
[0076] Reference is first made to FIGS. 1A-1B and 2A-2B, which
depict various details regarding a catheter insertion tool
("insertion tool"), generally depicted at 10, according to one
embodiment. As shown, the insertion tool 10 includes a housing 12
that in turn includes a top housing portion 12A separably mated
with a bottom housing portion 12B. A needle hub 14 supporting a
hollow needle 16 is interposed between the housing portions 12A and
12B. The needle 16 extends distally from the needle hub 14 so as to
extend through the body of the insertion tool 10 and out a distal
end of the housing 12. In another embodiment, the needle is at
least partially hollow while still enabling the functionality
described herein.
[0077] A notch 18 is defined through the wall of the needle 16
proximate the distal end thereof. The notch 18 enables flashback of
blood to exit the lumen defined by the hollow needle 16 once access
to the patient's vasculature is achieved during catheter insertion
procedures. Thus, blood exiting the notch 18 can be viewed by a
clinician to confirm proper needle placement in the vasculature, as
will be explained further below.
[0078] The insertion tool 10 further includes a guidewire
advancement assembly 20 for advancing a guidewire 22 through the
needle 16 and into the vasculature of the patient once access by
the needle has been achieved. The guidewire 22 is pre-disposed
within the lumen of the needle 16, with a proximal end of the
guidewire positioned proximate the proximal end of the needle hub
14, as best seen in FIGS. 1B and 2A. The guidewire advancement
assembly 20 includes a guidewire lever 24 that selectively advances
the guidewire in a distal direction during use of the insertion
tool 10 such that the distal portion of the guidewire extends
beyond the distal end of the needle 16. The guidewire lever 24
includes a lever tab 26 that engages the proximal end of the
guidewire 22 so to push the guidewire through the lumen of the
needle 16.
[0079] The guidewire advancement assembly 20 further includes a
slide 28 that is slidably attached to the top housing portion 12A.
Two tabs 24A of the guidewire lever 24 operably attach to the slide
28 so that selective movement by a user of the slide results in
corresponding movement of the lever 24, and by extension, the
guidewire 22. Engagement of the lever tabs 24A to the slide 28 also
maintains attachment of the slide to the housing 12. Of course,
other engagement schemes to translate user input to guidewire
movement could also be employed. Suitable tracks are included in
the top housing portion 12A to enable sliding movement of the slide
28 and the lever 24, including a track 34 extending to the distal
end of the housing 12.
[0080] The slide 28 includes two arms 30 that wrap partially about
rails 32 defined by the housing 12. In particular, during initial
distal advancement of the slide 28, the arms 30 slide on a bottom
housing rail 32A, best seen in FIG. 5B. During further distal
advancement of the slide 28, the arms 30 slide past the bottom
housing rail 32A and on to a top housing rail 32B, best seen in
FIGS. 2A and 3A. With the arms 30 of the slide 28 no longer engaged
with the bottom housing rail 32A, the two housing portions 12A and
12B are able to separate, as will be described further below.
[0081] The guidewire lever 24 includes a locking arm 36 resiliently
disposed so as to spring up and engage an extension 36A defined in
the interior of the top housing portion 12A when the slide 28 has
been fully slid distally. This prevents inadvertent retraction of
the guidewire 22 once distally extended, which could otherwise
cause unintended severing of a distal portion of the guidewire by
the distal tip of the needle 16 during insertion procedures. Note
that engagement of the locking arm 36 with the extension 36A can
provide tactile and/or audible feedback to the user in one
embodiment so as to indicate full distal extension of the guidewire
22.
[0082] The insertion tool 10 further includes a catheter
advancement assembly 40 for selectively advancing in a distal
direction a catheter 42, pre-disposed in the housing 12, and
including a catheter tube 44 and a hub 46 at a proximal end
thereof. As seen in FIGS. 1A and 1B, the catheter 42 is partially
and initially pre-disposed within a volume defined by the housing
12 such that the lumen of the catheter tube 44 is disposed over the
needle 16, which in turn is disposed over the guidewire 22, as
mentioned.
[0083] In particular, the catheter advancement assembly 40 includes
a handle 48 that defines a base 48A and two arms 50 extending from
the handle base. Each arm 50 defines a grip surface 50A, finger
grabs 50B, and one of two teeth 50C. The grip surfaces 50A and
finger grabs 50B enable the handle to be grasped or contacted by a
user in order to selectively advance the catheter 42 in a distal
direction during use of the insertion tool 10 to insert the
catheter into the body of the patient. The teeth 50C engage
corresponding raised surfaces on the hub 46 so as to removably
connect the handle 48 to the catheter 42.
[0084] Additional components are included in relation to the handle
48 of the catheter advancement assembly 40. A plug, or valve 52, is
interposed between the handle base 48A and the catheter hub 46 to
prevent blood spillage when the catheter is first introduced into
the patient vasculature. A safety housing 54, including a needle
safety component 56 therein, is removably attached to the handle 48
between the arms 50. Specifically, protrusions 60 included on the
inner surfaces of the handle arms 50 engage with corresponding
recesses 62 (FIG. 10A) defined in the safety housing 54 to
removably secure the safety housing to the handle 48. A cap 58
supports the needle safety component 56 and covers the end of the
safety housing 54. As shown in FIG. 1B, the needle 16 initially
extends through the aforementioned components in the order as shown
in FIG. 2B. Further details regarding the operation of these
components are given below.
[0085] Note that in one embodiment the outer diameters of the
needle 16 and the catheter tube 44 are lubricated with silicone or
other suitable lubricant to enhance sliding of the catheter tube
with respect to the needle and for aiding in the insertion of the
catheter into the body of the patient.
[0086] The insertion tool 10 further includes a support structure
70 for stabilizing the needle 16 proximate its point of exit from
the housing 12. In the present embodiment, the support structure 70
includes an interface 72 of the top housing portion 12A and bottom
housing 12B that is shaped to closely match the round shape of the
needle 16 and catheter tube 44. The interface 72 stabilizes the
needle 16 so as to prevent excessive "play" in the needle, thus
improving user accuracy when initially accessing the vasculature of
the patient.
[0087] As best seen in FIG. 2A, the top housing 12A, the needle hub
14, and the bottom housing 12B include engagement features 68 to
maintain attachment of the proximal end of the housing 12 even when
more distal portions of the housing are separated, discussed below.
Note, however, that various types, sizes, and numbers of engagement
features can be employed to achieve this desired functionality.
[0088] FIGS. 3A-9 depict various stages of use of the insertion
tool 10 in placing the catheter 42 in the vasculature of a patient.
For clarity, the various stages are depicted without actual
insertion into a patient being shown. With the insertion tool 10 in
the configuration shown in FIG. 1A, a user grasping the insertion
tool 10 first guides the distal portion of the needle 16 through
the skin at a suitable insertion site and accesses a subcutaneous
vessel. Confirmation of proper vessel access having been achieved
is evident via blood flash, i.e., the presence of blood between the
outer diameter of the needle 16 and the inner diameter of the
catheter tube 44 due to blood passing out the notch 18 from the
hollow interior of the needle. Note that in one embodiment, the
presence of blood in the safety housing 54, which in one embodiment
is a translucent housing, can serve as a secondary blood flash
indicator due to blood entering the housing from the needle 16 when
the vessel is accessed.
[0089] After needle access to the vessel is confirmed, the
guidewire advancement assembly 20 is actuated, wherein the slide 28
is advanced by the finger of the user to distally advance the
guidewire 22 (FIGS. 3A and 3B), initially disposed within the
hollow needle 16. Note that the guidewire is distally advanced by
the lever 24, which is operably attached to the slide 28. Note also
that during distal advancement of the slide 28, the slide arms 30
thereof travel along the rails 32 on either side of the housing 12:
first the bottom housing rails 32A, then the top housing rails
32B.
[0090] Distal guidewire advancement continues until the slide 28
has been distally slid its full travel length, resulting in a
predetermined length of the guidewire 22 extending past the distal
end of the needle 16, as shown in FIGS. 4A and 4B. In one
embodiment, further distal advancement of the slide 28 is prevented
by contact of the lever tab 26 with a distal portion of the needle
hub 14, as shown in FIG. 4B. FIGS. 5A and 5B show that, upon full
distal advancement of the slide 28, the slide arms 30 thereof are
no longer engaged with the bottom housing rails 32A, but rather
with only the top housing rails 32B. This in turn enables the
housing portions 12A and 12B to separate, as seen further
below.
[0091] As seen in FIGS. 5A and 5B, once the guidewire 22 has been
fully extended within the vessel of the patient (FIGS. 4A and 4B),
the catheter advancement assembly 40 is actuated, wherein the
handle 48 is distally advanced by the user to cause the catheter
tube 44 to slide over distal portions of the needle 16 and
guidewire 22 and into the patient's vasculature via the insertion
site. FIGS. 6A and 6B show that, as the catheter is advanced via
the handle 48, the housing portions 12A and 12B are easily
separated so as to enable the catheter hub 46 to exit the distal
end of the housing 12 and for the catheter to be inserted into the
patient vasculature to a suitable degree.
[0092] Note that, as shown in FIGS. 7A and 7B, during removal of
the catheter from within the housing 12 of the insertion tool 10,
the catheter slides distally along the needle 16 until the distal
needle tip is received into the safety housing 54 and engaged with
the needle safety component 56. FIG. 8 shows that the insertion
tool 10 can then be separated from the catheter 42, leaving the
handle 48 still attached to the catheter hub 46. As mentioned, the
handle 48 includes the valve 52 interposed between the catheter hub
46 and the handle 48. Upon removal of the needle 16 and safety
housing 54 from the catheter 42, the valve 52 occludes the catheter
lumen so as to prevent inadvertent blood spillage from the catheter
hub 46. As shown in FIG. 9, the handle 48 can be removed from
engagement with the catheter hub 46 via pulling, twisting, etc., so
as to disengage the teeth 50C of the handle from the hub. An
extension leg can be attached to the catheter hub and the catheter
42 dressed down, per standard procedures. Then housing 12 and
handle 48 of the insertion tool 10 can be discarded.
[0093] FIGS. 10A-10C give further details regarding the safety
housing 54, as well as the needle safety component 56 and its
interaction with the needle 16 in isolating the distal end thereof.
As shown, the safety housing 54 is configured to enable the needle
16 to pass therethrough during use of the insertion tool 10, as has
been described, exiting the housing via the extension 74 on the
distal end of the housing. The cap 58 is placed into the proximal
end of the safety housing 54 and is configured to support the
needle safety component 56 such that the needle 16 initially passes
through the safety housing, the cap, and the needle safety
component. Note that the extension 74 of the safety housing 54 in
the present embodiment extends into the valve 52 so as to open the
valve during use of the insertion tool 10, which eliminates
undesired friction between the valve and the needle.
[0094] FIG. 10C shows that the needle safety component 56 includes
a bent body, or binding element 80 through which the needle
initially extends, and a friction element 82. As seen in FIG. 10A,
when the needle 16 is withdrawn from the catheter 42 (FIG. 8), the
distal tip of the needle is withdrawn proximally through the
extension 74 and past the distal portion of the needle safety
component such that the needle is no longer in contact therewith.
This enables the friction element 82 to cause the binding element
80 to cant slightly, thus binding the needle 16 in place and
preventing its further travel with respect to the safety housing 54
and isolating the needle distal tip within the housing so as to
prevent inadvertent needle sticks. In the present embodiment the
friction element 82 includes a suitably sized O-ring. Suitable
O-rings can be acquired from Apple Rubber Products, Lancaster,
N.Y., for instance. Note that further details regarding the needle
safety component, its operating principles, and similar devices are
disclosed in U.S. Pat. Nos. 6,595,955, 6,796,962, 6,902,546,
7,179,244, 7,611,485, and 7,618,395, each of which is incorporated
herein by reference in its entirety. Of course, other needle safety
devices can be employed to isolate the distal end of the
needle.
[0095] Reference is now made to FIGS. 11A-13B in describing a
catheter insertion tool 110 according to one embodiment. Note that
in this and succeeding embodiments, various features are similar to
those already described in connection with the above embodiment. As
such, only selected aspects of each embodiment to follow will be
described.
[0096] The insertion tool 110 includes a housing 112 defined by a
top housing portion 112A and a bottom housing portion 112B that
together partially enclose the catheter 42. A needle hub 114
supporting a distally extending needle 116 is included for disposal
within the housing 112 and positioned such that the catheter tube
44 of the catheter 42 is disposed over the needle. Note that
partial enclosure of the catheter by the insertion tool in this and
other embodiments enables a clinician to manipulate the insertion
tool with hands that are closer to the distal end of the needle
than what would otherwise be possible.
[0097] FIGS. 13A and 13B give further details regarding the needle
hub 114, which is attached to the top housing portion 112A. A
needle holder 126, included on a distal end of the needle hub 114,
receives the proximal end of the needle 116 therein. The needle 116
is secured within the needle holder 126 via adhesive, welding, or
other suitable manner. Extensions 128 are included on opposite
sides of the needle holder 126 and are configured to be slidably
received within corresponding slots 130 defined on the sides of the
bottom housing portion 112B. Such engagement enables the bottom
housing portion 112B to slide distally with respect to the top
housing portion 112A.
[0098] A top rail 132 is included on the needle hub 114 and is
configured to engage a corresponding slot 134 defined in the
proximal portion of the top housing portion 112A so as to secure
the needle hub to the top housing portion. A lock out arm 136 is
also included with the needle hub 114 and positioned to engage the
back plate 124 when the bottom housing portion 112B is slid
distally to extend the guidewire from the needle 116, thus
preventing its retraction. Note that the guidewire 122 initially
distally extends from the back plate 124 and through the needle
holder 126 and needle 116, as best seen in FIG. 11D.
[0099] A guidewire advancement assembly 120 is included to
selectively advance a guidewire 122, initially disposed within the
lumen of the needle, distally past the distal end of the needle
116. The guidewire advancement assembly 120 includes the bottom
housing portion 112B to which the guidewire 122 is attached at a
proximal back plate 124 thereof. As will be seen, the bottom
housing portion 112B is distally slidable with respect to the top
housing portion 112A to enable selective distal advancement of the
guidewire 122.
[0100] The insertion tool 110 further includes a catheter
advancement assembly 140 for selectively advancing the catheter 42
over the needle 116. The advancement assembly 140 includes a handle
146 initially and slidably disposed between the top and bottom
housings 112A and 112B and removably attached to the hub 46 of the
catheter 42. As best seen in FIGS. 12A and 12B, the handle 146
includes two arms 150 for allowing a user to selectively slide the
handle in order to advance the catheter 42. The handle 146 further
includes a recess 152 in which is placed a needle safety component
156 for isolating the distal tip of the needle 116 when the needle
is withdrawn from the catheter 42. Further details regarding the
needle safety component are disclosed in U.S. Pat. Nos. 6,595,955,
6,796,962, 6,902,546, 7,179,244, 7,611,485, and 7,618,395, each
incorporated by reference above.
[0101] The insertion tool 110 further includes a support structure
170 for stabilizing the needle 116 proximate the distal end of the
housing 112. The support structure 170 in the present embodiment
includes two flaps 172 that are hingedly connected to the distal
portion of the bottom housing portion 112B. When closed as seen in
FIGS. 11D and 12A, the flaps 172 serve to stabilize the needle 116
to assist the user of the insertion tool 110 in inserting the
needle into the patient. When open (FIG. 14D), the flaps 172
provide an opening to enable the catheter hub 46 to be removed from
the distal end of the housing 112, as will be detailed further
below. Before the bottom housing portion 112B is slid with respect
to the top housing portion 112A, the flaps 172 are disposed in a
track 174 defined by the top housing portion. Other types and
configurations of support structures can also be employed. The
insertion tool 110 further includes gripping surfaces 176 on either
side of the housing 112 to aid in use of the tool during catheter
insertion procedures, detailed below.
[0102] FIGS. 14A-14E depict various stages of use of the insertion
tool 110 in inserting a catheter into a patient. With the insertion
tool 110 in the configuration shown in FIG. 14A, vascular access is
achieved with the needle 116 via user insertion of the needle into
the patient at an insertion site. Confirmation of vessel access can
be achieved via the observation of blood flashback via a distal
notch in the needle 116, as described in the previous embodiment,
or in other suitable ways.
[0103] Once the distal portion of the needle 116 is disposed within
a vessel of the patient, the guidewire 122 is extended past the
distal end of the needle and into the vessel by distally advancing
the bottom housing portion 112B. Such advancement is achieved in
the present embodiment by placing a user's fingers on the folded-up
flaps 172 of the bottom housing portion 112B and pushing the flaps
distally, thus extending the guidewire 122. The guidewire 122 is
advanced until fully extended. The lock out arm 136 of the needle
hub 114 then engages the back plate 124 of the bottom housing
portion 112B and prevents retraction of the guidewire 122.
[0104] At this stage, the handle 146 of the catheter advancement
assembly 140 is distally advanced, by a user grasping of one or
both arms 150 thereof, so as to distally advance the catheter 42
through the insertion site and into the patient vasculature. This
is shown in FIG. 14C, wherein the catheter tube 44 is shown
distally advancing over the needle 116 and the guidewire 122.
[0105] As shown in FIG. 14D, continued distal advancement of the
catheter 42 causes the catheter hub 146 to urge the flaps 172 to
open, thus providing a suitable opening through which the hub may
pass from the insertion tool housing 112. Note that the flaps 172
are shaped such that contact with the catheter hub 46 urges each
flap to fold outward, as seen in FIG. 14D. Note also that the flaps
172 are no longer disposed within the track 174 due to full distal
advancement of the guidewire 122 via finger pressure applied to the
flaps 172 as described above.
[0106] FIG. 14E shows that, with the flaps no longer engaged within
the track 174, the top housing portion 112A and bottom housing
portion 112B are able to separate at the distal ends thereof such
that the handle 146, still attached to the catheter hub 46, can
separate from the housing 112. Though not shown at this stage, the
needle safety component 156 disposed in the recess 152 of the
handle 146 isolates the distal end of the needle 116. The handle
146 can then be manually removed from the catheter hub 46 (FIG.
14F), and placement and dressing of the catheter 42 can be
completed. The insertion tool 110, including the needle 116
isolated by the needle safety component 156 of the handle 146, can
be safely discarded.
[0107] Reference is now made to FIGS. 15A-18 in describing a
catheter insertion tool 210 according to one embodiment. The
insertion tool 210 includes a housing 212 defined by a top housing
portion 212A and a bottom housing portion 212B that together
partially enclose the catheter 42. A sliding needle hub 214
supporting a distally extending hollow needle 216 is slidably
attached to the housing 212. In particular, the needle hub 214
includes tracks 214A that slidably engage corresponding rails 218
defined on the top and bottom housing portions 212A, 212B in a
manner described further below. As shown in FIG. 15A, the needle
hub 214 is positioned distally with respect to the housing 212 such
that the needle 216 extends through a needle channel 224 (FIG. 18)
and out a hole defined in a distal end of the top housing portion
212A so that the needle is positioned as shown in FIG. 15A.
[0108] As seen in FIG. 15A, the housing 212 of the insertion tool
210 encloses a portion of the catheter 42. An integrated
guidewire/dilator 220 is included and disposed within the lumen of
the catheter tube 44, as shown in FIGS. 15B and 16. The
guidewire/dilator 220 includes a distal guidewire portion 220A and
a proximal dilator portion 220B. So configured, the
guidewire/dilator 220 can not only serve as a guidewire in
directing the catheter tube 44 through the insertion site of the
patient into the accessed vessel, but can dilate the insertion site
in advance of catheter insertion therethrough. In other embodiment,
no guidewire/dilator need be used. In one embodiment, it is
appreciated that the guidewire/dilator 220 can proximally extend
through the entire catheter 42 and include on a proximal end
thereof a luer cap connectable to a proximal luer connector of the
catheter. Note also that FIG. 15A shows a sterile bag 217 attached
to the housing 212 so as to cover and isolate the proximal portion
of the catheter 42. For clarity, the bag 217 is included only in
FIG. 15A, but could be included with insertion tools of varying
configurations so as to protect and isolate portions of the
catheter.
[0109] As seen in FIGS. 17A-17C, the needle 216 includes a
longitudinally extending needle slot 226 extending from a beginning
point along the length of the needle to the distal end thereof.
FIG. 17B shows that the slot 226 can be optionally wider in a
proximal portion thereof relative to more distal slot portions. So
configured, the needle slot 226 enables the guidewire/dilator 220
to be inserted into, slid relative to, and removed from the needle
216 during operation of the insertion tool 210, described below.
Note that the needle slot can extend the entire length of the
needle, in one embodiment.
[0110] FIG. 18 shows the manner of entry of the guidewire/dilator
220 into the slot 226 of the needle 216 according to one
embodiment, wherein the guidewire/dilator extends distally along a
guide channel 222 defined in the top housing portion 212A and into
the hollow needle 216, which is disposed in the needle channel 224,
via the needle slot. (The guide channel 222 is also seen in FIG.
15B.) In this way, the guidewire/dilator 220 can be distally slid
through the hollow needle 216 so as to extend beyond the distal
needle end while still being able to be removed from the needle via
the slot 226 when the guidewire/dilator and needle are separated
from one another, as will be seen.
[0111] FIG. 18 also shows a support structure 270 for stabilizing
the needle 216, including an interface 272 defined by portions of
the top housing portion 212A and the bottom housing portion 212B
about the hole through which the needle extends. Of course, other
support structures can be employed to provide stability to the
needle to assist in inserting the needle into the patient
vasculature. FIG. 19 shows details of a lockout 230 for the needle
hub 214, included on the bottom housing portion 212B, for
preventing further movement of the needle hub after it has been
retracted, as described below.
[0112] FIGS. 19-24 depict various stages of use of the insertion
tool 210 in inserting a catheter into a patient. With the insertion
tool 210 in the configuration shown in FIG. 19, vascular access is
achieved with the needle 216 via user insertion of the needle into
the patient at an insertion site.
[0113] Once the distal portion of the needle 116 is disposed within
a vessel of the patient, the guidewire/dilator 220 is manually fed
through the hollow needle 216 so as to extend past the distal end
of the needle and into the vessel. Such advancement is achieved in
the present embodiment by distally moving the housing 212 and
catheter 42 together while keeping the needle hub 214 stationary.
The guidewire 122 is advanced distally a suitable distance, which
in the present embodiment, includes advancement until a distal end
of the housing 212 arrives at the skin insertion site.
[0114] FIGS. 20A and 20B show that after the guidewire/dilator 220
has been distally extended into the vessel, the needle 216 is
retracted from the vessel by proximally sliding the needle hub 214
along rail portions 218A disposed on the top housing portion 212A.
Proximal sliding of the needle hub 214 continues until the hub
engages the rail portions 218B of the bottom housing portion 212B
and is fully slid to the proximal end of the housing 212, as shown
in FIGS. 21A and 21B. The needle hub 214 engages the lock out 230
(FIG. 20B) so as to prevent future distal movement of the needle
hub or needle 216. In this position, the needle 216 is fully
retracted into the insertion tool housing 212 such that the distal
end of the needle is safely isolated from the user (FIG. 21B). Note
that in one embodiment a needle safety component can be added to
the insertion tool to further isolate the tip of the needle. Note
that the distal portion of the guidewire/dilator 220 remains in the
vessel of the patient, having been able to separate from the needle
216 during retraction thereof via the needle slot 226.
[0115] At this stage, the bottom housing portion 212B (FIG. 22) and
the top housing portion 212A (FIG. 23) are removed from the
catheter 42. The catheter 42 can then be inserted through the
insertion site and into the vessel of the patient. Note that the
guidewire/dilator 220 is still disposed within the catheter tube 44
and that the dilator portion assists the distal end of the catheter
tube to enter the vessel by gradually enlarging the insertion site
and the vessel entry point.
[0116] As mentioned, in one embodiment, the proximal portion of the
catheter 42, including the hub 46 and connected extension leg, is
covered by a sterile bag, which is attached to the housing 212. The
sterile bag can be removed after the catheter is fully inserted
into the patient vessel or can be removed when the housing portions
212A and 212B are removed. In FIG. 24, the guidewire/dilator 220 is
then removed from the catheter 42 and the catheter dressed and
finalized for use. The guidewire/dilator 220 and other portions of
the insertion tool 210 are discarded.
[0117] FIGS. 25A and 25B depict details regarding a needle blunting
system for isolating a distal end 316A of a hollow needle 316,
according to one embodiment. As shown, the needle distal end 316A
includes a bevel that is configured such that its cutting surfaces
are disposed at an inner diameter 318 of the needle 316. Thus, when
a suitably sized guidewire 320 is distally extended past the distal
end 316A of the needle 316, the cutting surfaces of the needle are
blocked by the proximity thereto of the guidewire, thus safely
isolating the needle end from a user. In addition, blunting the
distal end 316A of the needle 316 in this manner prevent the needle
end from damaging sensitive inner walls of the vessel after the
needle tip has been inserted herein. At this point, a distal end
44A of the catheter tube 44 can then be distally advanced over the
needle 316 and guidewire 320. FIG. 26 depicts a needle end bevel
316A according to another embodiment, including an additional
fillet component 319. Such a blunting system can be employed in one
or more of the insertion tools described herein.
[0118] Reference is now made to FIG. 27 in describing a catheter
insertion tool 410 according to one embodiment. The insertion tool
410 includes a housing 412 that partially encloses the catheter 42.
A distally extending hollow needle 416 is disposed with the housing
412 such that the needle extends out the distal end of the housing
412
[0119] A guidewire advancement assembly 420 is shown for
selectively advancing a guidewire 422, including a slide 428 that
slides along a track 430 defined in the housing 412. The guidewire
422 is attached to the slide 428 and extends proximally within the
housing 412 until it bends, forming a guidewire bend 422A, toward
the distal end of the housing and passes into the hollow needle 416
via a proximal end 416A thereof for selective distal advancement
past the distal end of the needle via user actuation of the slide.
Distal advancement of the guidewire 422 out the distal end of the
needle 416 is stopped when the guidewire bend 422A engages the
needle proximal end 416A.
[0120] A catheter advancement assembly 440 is also shown for
selectively advancing the catheter tube 44 over the needle 416,
including a slide 448 that slides along the track 430, and a
carriage 450 disposed within the housing 412 and operably connected
to the slide 448. The carriage 450 is initially engaged with the
catheter hub 46 such that distal sliding of the slide 448 causes
the catheter to be distally advanced toward the distal housing
end.
[0121] The insertion tool 410 further includes a support structure
470 for stabilizing the needle 416, including two doors 472
hingedly attached via pins to the distal end of the housing 412.
The doors 472 serve to stabilize the needle 416 during insertion
into the patient. Later, when the catheter tube 44 and catheter hub
46 are advanced distally by the slide 448, the doors 472 are
opened, enabling the catheter 42 to pass through the doors and be
separated by the user from the insertion tool 410. In the present
embodiment, a wedge feature is included on the bottom surface of
the slide 428, the wedge feature being configured to push the doors
472 open when the slide is slid distally, as described herein. Such
a wedge or other suitable feature can be included in other
embodiments described herein as well.
[0122] After separation from the insertion tool 410, the catheter
42 can then be advanced and placed as needed into the patient by
the user. Note that, though none is shown, a needle safety
component can be included for isolating the distal tip of the
needle 416. In one embodiment, distal sliding of the guidewire
slide 428 can partially open the doors 472 in preparation for
catheter advancement.
[0123] FIG. 28 shows the insertion tool 410 including a support
structure 480 according to another embodiment, wherein two
half-conically shaped doors 482 are hingedly connected to the
housing 412 (via living hinges or other suitable connective scheme)
and configured to stabilize the needle 416. The carriage of the
insertion tool 410 in FIG. 28 is also longer relative to that of
FIG. 27. Thus, it is appreciated that various different support
structures and configurations can be employed for stabilizing the
needle at or near its exit point from the insertion tool
housing.
[0124] Reference is now made to FIGS. 29A and 29B in describing a
catheter insertion tool 510 according to one embodiment. The
insertion tool 510 includes a housing 512 that partially encloses
the catheter 42. A hollow needle 516 distally extends from a needle
hub 514 that caps a proximal end of the housing 512 such that the
needle extends out the distal end of the housing 512.
[0125] A guidewire advancement assembly 520 is shown for
selectively advancing a guidewire 522, including a slide 528 that
slides along a track 530 defined in the housing 512. The guidewire
522 is attached to the slide 528 and extends proximally within the
housing 512 and out through a pigtail 524, attached to the proximal
end of the housing 512, via a top one of two holes 514A defined in
the needle hub 514. Near the proximal end of the pigtail 524, the
guidewire 522 bends to form a U-shaped guidewire bend 522A and
distally extends back into the housing 512 to pass into the hollow
needle 516 via a bottom one of the two needle hub holes 514A, for
eventual distal advancement out the distal end of the needle when
the slide 528 is selectively actuated by a user. Such distal
advancement of the guidewire 522 out the distal end of the needle
416 is stopped when the guidewire bend 522A abuts the holes 514A
defined in the needle hub 514.
[0126] A catheter advancement assembly 540 is also shown for
selectively advancing the catheter tube 44 over the needle 516,
including a slide 548 that slides along the track 530, and a
carriage 550 disposed within the housing 512 and operably connected
to the slide. The carriage 550 can be initially engaged with the
catheter hub 46 such that distal sliding of the slide 548 causes
the catheter to be distally advanced toward the distal housing end.
In the present embodiment a bulge 522B is included on the guidewire
522 such that, when the guidewire is distally advanced by user
actuation of the (guidewire advancement) slide 528, the bulge is
advanced and engages an internal portion of the (catheter
advancement) slide 548. This in turn causes the slide 548 to be
advanced as well, resulting in distal advancement of the catheter
42. Thus, the catheter can be advanced directly via the slide 548,
or indirectly via the slide 528, in one embodiment.
[0127] The insertion tool 510 further includes a support structure
570 for stabilizing the needle 516, including a plug 572 that
includes a plug hole 574 defined therein through which the needle
516 extends. The plug 572 is attached via the track 530 to the
slide 528 and occludes the distal end of the housing 512, thus
serving to stabilize the needle 516 that passes therethrough during
needle insertion into the patient. Later, when the guidewire 522 is
advanced distally by the slide 528, the plug 572 also distally
advances out the housing 512, thus opening the housing distal end
and enabling the catheter 42 to pass therethrough. The catheter 42
can then be separated by the user from the insertion tool 510 and
advanced into final position by the user. Note that, though none is
shown, a needle safety component can be included for isolating the
distal tip of the needle 516. Note also that after the plug 572 is
removed from its initial position in the housing 512, the catheter
tube 44 and needle 516, no longer being constrained by the support
structure plug hole 574, can axially relocate toward the center of
the housing, in one embodiment. This holds true for the embodiments
of FIGS. 30 and 31 as well.
[0128] Reference is now made to FIG. 30 in describing a catheter
insertion tool 610 according to one embodiment. The insertion tool
610 includes a housing 612 that partially encloses the catheter 42.
A hollow needle 616 distally extends from a needle hub 614 that
caps a proximal end of the housing 612 such that the needle extends
out the distal end of the housing 612. The needle 616 includes a
longitudinally extending proximal slot 616A that extends from the
proximal end of the needle 616 to a distal end 616B of the
slot.
[0129] A guidewire advancement assembly 620 is shown for
selectively advancing a guidewire 622, including a slide 628 that
slides along a track 630 defined in the housing 612. The guidewire
622 is attached to the slide 628 and extends proximally within the
housing 612 until it bends, forming a U-shaped guidewire bend 622A,
toward the distal end of the housing and passes into the hollow
needle 616 via the proximal slot 616A thereof for selective distal
advancement past the distal end of the needle via user actuation of
the slide. Note that distal advancement of the slide 628 causes the
slide to separate from the housing 612 while still being attached
to the guidewire 622. Distal advancement of the guidewire 622 out
the distal end of the needle 616 is stopped when the guidewire bend
622A engages the distal end 616B of the proximal slot 616A of the
needle.
[0130] A catheter advancement assembly 640 is also shown for
selectively advancing the catheter tube 44 over the needle 616,
including a carriage 650 disposed within the housing 612 and
operably connected to the slide 628 such that actuation of the
slide distally advances both the guidewire 622 and the carriage
650. The carriage 650 is not initially engaged with the catheter
hub 46, but engages the hub after an amount of distal advancement.
This in turn causes the catheter 42 to be distally advanced toward
the distal housing end.
[0131] The insertion tool 610 further includes a support structure
670 for stabilizing the needle 616, including a plug 672 that
includes a plug hole 674 defined therein through which the needle
616 extends. The plug 672 is attached via the track 630 to the
slide 628 and occludes the distal end of the housing 612, thus
serving to stabilize the needle 616 that passes therethrough during
needle insertion into the patient. Later, when the guidewire 622 is
advanced distally by the slide 628, the plug 672 also distally
advances out the housing 612, thus opening the housing distal end
and enabling the catheter 42 to pass therethrough. The catheter 42
can then be separated by the user from the insertion tool 610 and
advanced into final position by the user. Note that, in one
embodiment, the carriage 650 can include a needle safety component
for isolating the distal end of the needle 616.
[0132] Reference is now made to FIG. 31 in describing a catheter
insertion tool 710 according to one embodiment. The insertion tool
710 includes a housing 712 that partially encloses the catheter 42.
A hollow needle 716 distally extends from a needle hub 714 that
caps a proximal end of the housing 712 such that the needle extends
out the distal end of the housing 712.
[0133] An advancement assembly 720 is shown for selectively
advancing a guidewire 722 and catheter 42. The advancement assembly
720 includes a wheel 730, selectively rotatable by a user, that is
attached via a filament 726 or other suitable component to a
carriage 750. The guidewire 722 is attached to the carriage 750 and
extends proximally within the housing 712 and out through a pigtail
724, attached to the proximal end of the housing 712, via a one of
two holes defined in the needle hub 514 (similar to the holes 514A
in the needle hub 514 of FIGS. 29A, 29B). Near the proximal end of
the pigtail 724, the guidewire 722 bends to form a U-shaped
guidewire bend 722A and distally extends back into the housing 712
to pass into the hollow needle 716 via the other of the two holes
defined in the needle hub 714 for eventual distal advancement out
the distal end of the needle when the wheel 730 is selectively
actuated by a user. Such distal advancement of the guidewire 722
out the distal end of the needle 716 is stopped when the guidewire
bend 722A abuts the above-mentioned holes defined in the needle hub
714.
[0134] The advancement assembly 720 selectively advances the
catheter tube 44 over the needle 716 and includes the
aforementioned carriage 750 disposed within the housing 712 and
operably connected to the wheel 730 via the filament 726 such that
rotation of the wheel distally advances the carriage 750. The
guidewire 722, a proximal end of which being attached to the
carriage 750, is also advanced distally through the needle, as
described above. Note that in one embodiment the wheel 730, by
virtue of the non-rigid filament 726 connecting the wheel to the
carriage 750, ensures that the guidewire 722 is only distally
advanced, and not proximally retractable.
[0135] Distal advancement of the carriage 750 causes the
carriage--which is not initially engaged with the catheter hub
46--to engage the hub after an amount of distal advancement. This
in turn causes the catheter 42 to be distally advanced toward the
distal housing end.
[0136] The insertion tool 710 further includes a support structure
770 for stabilizing the needle 716, including a door 772 hingedly
attached to the distal end of the housing 712 and including a hole
774 therein for enabling passage of the needle 716 therethrough.
The door 772 serves to stabilize the needle 716 during insertion
into the patient. Later, when the catheter tube 44 and catheter hub
46 are advanced distally by the wheel 730 and the carriage 750, the
door 772 is pushed open by the hub, enabling the catheter 42 to be
separated by the user from the insertion tool 710. The catheter 42
can then be advanced for final placement within the patient by the
user. Note that, though none is shown, a needle safety component
can be included for isolating the distal tip of the needle 716.
[0137] Reference is now made to FIGS. 32A-32I in describing a
catheter insertion tool 810 according to one embodiment. The
insertion tool 810 includes a housing 812 that at least partially
encloses the catheter 42. A hollow needle 816 distally extends from
a needle hub 814 included within the housing 812 such that the
needle initially extends out the distal end of the housing 812. The
needle 816 includes a distal slot 816A, similar to the previously
described needle slot 226 (FIGS. 17A-17C), for enabling a
guidewire/dilator 822, similar to the previously described
guidewire/dilator 220 (FIG. 16) to be removably inserted therein.
The catheter 42 is disposed over the guidewire/dilator 822.
[0138] The needle hub 814 further includes a needle retraction
system 818 for selectively retracting the needle 816 into the
housing 812 so as to isolate the distal tip of the needle from the
user in a safe manner. The retraction system 818 includes a spring
819 or other suitable retraction device operably coupled to the
needle 816 for effecting the needle retraction.
[0139] An advancement assembly 820 is shown for selectively
advancing the guidewire/dilator 822 as well as the catheter 42. The
advancement assembly 820 includes a slide 828 that travels in a
track 830 defined in the housing 812. The slide 828 is operably
attached to a ratchet bar 824 slidably disposed within the housing
812. The ratchet bar 824 includes a plurality of upper teeth 826
for selective catheter advancement, and at least one lower tooth
826A for actuating a retraction trigger 880 of the needle
retraction system 818, as will be described. The hub 46 of the
catheter 42 disposed within the housing 812 has removably attached
thereto a cap 834 including a prong 836 for engaging the upper
teeth 826 of the ratchet bar 824.
[0140] The insertion tool 810 further includes a support structure
870 for stabilizing the needle 816, including a housing hole 872
defined by the distal end of the housing 812. The housing hole 872
is sized to provide stability to the needle 816 at its point of
exit from the housing.
[0141] FIGS. 32A-32I depict various stages of use of the insertion
tool 810 in inserting a catheter into a patient. With the insertion
tool 810 in the configuration shown in FIG. 32A, vascular access is
achieved with the needle 816 via user insertion of the needle into
the patient at an insertion site. Blood flashback can be observed
via the distal slot 816A of the needle 816 to confirm proper
positioning of the distal end of the needle within the patient's
vessel. As shown in FIG. 32B, the slide 828 is slid distally to
advance the guidewire/dilator 822, a distal portion of which is
pre-disposed within the needle 816 via the distal slot 816A,
distally out the distal end of the needle and into the vessel of
the patient. As shown, the guidewire/dilator 822 is advanced
indirectly by the ratchet bar 824, which is moved by the slide 828.
In particular, a proximate one of the upper teeth 826 of the
ratchet bar 824 engages the prong 836 of the cap 834 fitted over
the catheter hub 46. Thus, when the slide 828 and ratchet bar 824
are moved distally, the catheter 42 and guidewire/dilator 822
disposed therein are also moved distally, as shown in FIG. 32B.
Similar ratcheting movement occurs in the successive steps as
well.
[0142] Sliding of the slide 828 in the stage shown in FIG. 32B also
causes the bottom tooth 826A of the ratchet bar 824 to engage the
retraction trigger 880 of the needle retraction system 818. This in
turn enables the spring 819 to expand and retract the needle 816
and retraction system 818 into the housing 812 such that the distal
tip of the needle is isolated from the user within the housing.
[0143] FIG. 32C shows the return of the slide 828 to its initial
position, which causes the ratchet bar 824 to also return to its
initial position. Because the prong 836 of the cap 834 attached to
the catheter hub 46 is distally angled, however, the teeth 826 of
the ratchet bar slide past without retracting the catheter 42 such
that the catheter remains in position.
[0144] In FIG. 32D, the slide 828 is again distally advanced, which
causes a proximate upper tooth 826 of the ratchet bar 824 to engage
the cap prong 836 and further advance the guidewire/dilator 822
distally into the vessel. As it is disposed over the
guidewire/dilator 822, the catheter 42 at this or a successive
stage is also advanced into the vessel, depending on catheter
length, distance to insertion site, etc. The slide 828 is
subsequently retracted to its initial position, as shown in FIG.
32E. Note that ratchet retraction can be user activated or
automatically activated by a suitable system included in the
insertion tool 810.
[0145] In FIG. 32F, the slide 828 and ratchet bar 824 are again
distally advanced, resulting in further distal advancement out of
the housing 812 of the guidewire/dilator 822 and catheter 42. The
slide 828 is subsequently retracted to its initial position, as
shown in FIG. 32G. In FIG. 32H, the slide 828 and ratchet bar 824
are distally advanced a final time, resulting in near-complete
distal advancement of the guidewire/dilator 822 and attached
catheter 42 from the housing 812 of the insertion tool 810. At this
stage, the hub 46 of the catheter 42 can be grasped and the
catheter removed from the insertion tool 810, which can then be
discarded. Final positioning of the catheter 43 within the vessel
can then be manually performed by the user. The cap 834 is also
removed from the catheter hub 46.
[0146] FIGS. 33A-33C depict details of a needle safety component
for isolating the distal end 16A of the needle 16, the needle
including the distal notch 18 as discussed above in connection with
FIGS. 1A-10C, according to one embodiment. As shown, a safety
housing 954 including a hinged door is included so as to ride over
the needle 16. Two needle safety components 956 are oppositely
disposed within the safety housing 954 and each also rides over the
needle 16. Each needle safety component includes a base 958
defining a hole through which the needle 16 passes and a plurality
of arms 960. The arms 960 extend from the base 958 and converge
toward one another in conical fashion such that an end of each arm
abuts the needle surface. The arms 960 are configured to engage the
notch 18 defined in the distal portion of the needle 16 and prevent
further movement of the needle 16 with respect to the needle safety
component 956. In particular, each arm 960 compressively engages
the outer surface of the needle 16 such that when one of the arms
encounters the needle notch 18, the arm will descend into the notch
slightly so as to lock the needle 16 in place with respect to the
needle safety component 956. Two needle safety components 956 are
disposed in the safety housing 954 so as to prevent further needle
movement in either direction, distally or proximally. Thus, the
distal end 16A of the needle 16 is safely isolated within the
safety housing 954, as seen in FIGS. 33A-33C. Note that the needle
safety component described here is useful for isolating a needle
even when the guidewire 22 still extends therethrough, as seen in
FIG. 33C, for example.
[0147] In other embodiments, only one needle safety component as
described above may be used. Thus, the needle safety component
described here serves as one example of a variety of needle safety
components that may be employed in connection with the present
disclosure.
[0148] It is appreciated that in one embodiment the insertion tool
can include a sterile sheath or bag that is disposed over a distal
portion of the catheter that distally extends from the insertion
tool housing so as to isolate the catheter. The needle,
pre-disposed within the catheter and retractable into the insertion
tool housing, can extend from the bag to gain vascular access.
Thereafter, the bag can be compressed toward the housing as the
catheter is advanced into the vasculature, then disposed of once
the catheter is fully inserted. In one embodiment, the bag can
include a grip wing or other device that helps to grasp the
catheter or needle through the bag during insertion. Further note
that the insertion tools described herein can include a cap or
other protective device that is removably attached to the insertion
tool before use so as to preserve the sterility of the needle and
catheter.
[0149] Reference is now made to FIG. 34, which depicts an exploded
view of the catheter insertion device 10 according to one
embodiment, including components similar to those that have already
been described above. As such, only selected differences are
discussed below.
[0150] FIG. 34 shows that in the present embodiment the guidewire
22 is looped back on itself to substantially define a U-shaped
configuration. FIGS. 36A and 36B shows the manner in which the
guidewire 22 is disposed within the housing 12 of the catheter
insertion device 10. In particular, these figures show that a
proximal end of the guidewire 22 is anchored to a portion of the
device 10, namely, at an anchor point 982 on the top portion 12A of
the housing 12. FIG. 37 shows that the guidewire 22 extends
proximally and removably within a guide channel 984 defined on an
interior surface of the top housing portion 12A. FIGS. 36A and 36B
show that an intermediate portion of the guidewire 22 loops back on
itself proximate the proximal end of the device 10. Guide surfaces
980 (FIG. 35) disposed near the proximal end of the guidewire lever
24 constrain the flexible guidewire 22 into the looped,
substantially U-shaped configuration. The looped-back intermediate
portion of the guidewire 22 then extends toward the distal end of
the device 10 along a channel 986, best seen in FIG. 38, defined on
an interior surface of the bottom housing portion 12B of the
housing 12 before it passes into the hollow needle 16. The free
distal end of the guidewire 22 initially resides within the needle
16.
[0151] So disposed as described immediately above, the guidewire 22
is positioned for selective advancement by the guidewire
advancement assembly 20 such that the free distal end thereof can
distally extend from the open distal tip of the needle 16. This
selective advancement of the guidewire 22 is achieved in the
present embodiment via distal movement of the guidewire advancement
slide 28 included on the device housing 12. Distal movement of the
guidewire advancement slide 28 causes corresponding distal sliding
movement of the guidewire lever 24. The guide surfaces 980 of the
guidewire lever 24 push the bend of the guidewire 22 distally as
the lever advances. Note that the guidewire 22 is sufficiently
rigid so as to be advanced by the guidewire lever 24 without
buckling. Also, the guide surfaces 980 and guidewire 22 are
configured to enable retraction of the guidewire 22 back into the
insertion tool housing 12 when the guidewire advancement slide 28
or other suitable mechanism is slid proximally.
[0152] This pushing movement of the slidable guidewire lever 24
causes the distal end of the guidewire 22 to extend distally from
the open distal tip of the needle 16. Because of its anchored
proximal end at anchor point 982 and its bent or looped U-shape
configuration, the guidewire 22 is distally advanced at a rate of
about twice the rate of sliding of the guidewire advancement slide
28 and about twice the rate of guidewire advancement in the device
configuration of FIGS. 1A-9, which results in about twice the
length of guidewire extension when compared with the length of
movement of the guidewire advancement slide 28. This further
desirably results in a relatively longer length of guidewire
extension into the vein or other patient vessel so as to more
suitably guide the catheter 42 into the patient's body. As such,
the guidewire and advancement assembly described here operates as a
type of "reverse pulley" system for distal guidewire advancement.
Note that other looping configurations of the guidewire can be
included with the device 10 in addition to those shown and
described herein. Also, differing ratios of guidewire extension vs.
advancement assembly movement are also possible in other
embodiments.
[0153] Note that the looping conduit and guidewire advancement
handle are only examples of structures that can suitably perform
the desired functionality described herein. Indeed, other
structures can be employed to accomplish the principles described
in connection with the present embodiment. Also, though shown and
described above to be attached to the catheter insertion device
housing, the proximal end of the guidewire can be attached to other
structures within/on the device, such as the needle hub 14, for
instance. The majority length of the guidewire in one embodiment
includes a metal alloy of nickel and titanium commonly referred to
as nitinol, which is sufficiently rigid and can be disposed in the
U-shaped configuration without retaining a memory of that position
when the guidewire is advanced. Note that other suitable guidewire
materials can also be employed.
[0154] FIGS. 39A and 39B depict various details regarding the
binding element 80, described further above, of the needle safety
component 56 for shielding the distal tip of the needle 16 once
catheter insertion is complete. As shown, the binding element 80
(which is also referred to herein as a binding member) includes a
front plate 992 defining a hole 992A, and a forked back plate 994.
A protuberance 996 extends from one of the forks of the back plate
994. A horseshoe-shaped needle pass-through element 998 is also
included in a spaced-apart arrangement from the front plate 992 and
defines a hole 998A in coaxial alignment with the hole 992A of the
front plate.
[0155] A friction element 1000, also referred to herein as a
friction member, is also included with the binding element 80 in
the present embodiment, namely, an annular elastomeric element, or
O-ring 1002, as seen in FIGS. 40A and 40B. As shown, the O-ring
1002 is configured to wrap around both a portion of the needle 16
and the forked back plate 994. The protuberance 996 is employed to
aid in maintaining the O-ring 1002 in place as shown in FIGS. 40A
and 40B. With the O-ring 1002 so positioned, a relatively constant
urging force is imparted by the O-ring to the binding element 80,
for use in shielding the distal tip of the needle 16, as will be
described further below. Note that the elastomeric element can take
forms other than an O-ring while performing the same functionality.
For instance, a rod or length of elastomeric material that is
wrapped about a portion of the binding element and the needle could
also be employed.
[0156] FIGS. 40C and 40D show the binding element 80 disposed in
the carriage 1008, which is in turn disposed within the safety
housing 54. As shown, the carriage 1008 defines two constraining
surfaces 1010 against which corresponding portions of the front
plate 992 of the binding element initially rest when the needle 16
initially extends through the carriage and the binding element. A
retaining ring 1008A through which the needle 16 slidably passes
enables engagement of the needle with the carriage 1008.
[0157] The binding element 80 is initially slidably disposed with
the needle 16 in the state shown in 40A-40D (showing the binding
element before it has shielded the distal tip of the needle) such
that relative sliding movement between the needle and the binding
element is permitted. Passage of the needle 16 through the hole
998A of the needle pass-through element 998 initially limits
canting movement of the binding element 80.
[0158] The needle 16 also passes through the hole 992A of the front
plate 992 such that the needle is straddled by the forks of the
forked back plate 994. As mentioned, the O-ring 1002 is disposed
about the needle 16 and the back plate 994 so as to provide a drag
force when the carriage 1008 and binding element 80 (both housed
within the safety housing 54 (FIG. 34) are slid distally along the
length of the needle 16 during use of the device 10. The drag force
provided by the O-ring 1002 during such distal sliding in turn
imparts a rotational moment on the binding element 80 (by virtue of
forces provided via the contact of the binding element with the
O-ring) to urge the binding element to rotate in a clockwise
motion, from the perspective of the drawing shown in FIG. 40C.
[0159] Such clockwise rotation of the binding element 80 is
prevented by the needle pass-through feature 998 while the needle
16 extends through the binding element. Once the safety housing 54
containing the carriage 1008 and binding element 80 has been slid
distally a sufficient distance such that the needle pass-through
element 998 slides past and off the distal end of the needle 16,
however, the binding element is no longer constrained and the drag
force imparted by the O-ring 1002 causes the binding element to
cant clockwise with respect to the needle, from the perspective of
the drawing shown in FIG. 40C. This canting locks movement of the
binding element 80 and, by extension, the carriage 1008, with
respect to the needle 16, by virtue of physical binding between the
outer surface of the needle 16 with the perimeter of the front
plate hole 992A, which thus acts as a binding surface. With the
distal tip of the needle 16 safely disposed within the locked
carriage 1008, the user is thus protected from an accidental needle
stick.
[0160] As mentioned above, the O-ring 1002 imparts a relatively
constant urging force for canting the binding element 80, which
keeps the binding element canted (after withdrawal of the needle
distal tip into the carriage as described above) so as to more
securely lock the carriage 1008 over the distal tip of the needle
16. This constant urging force is beneficial, for example, in
instances when the needle 16 is pushed back and forth with respect
to safety housing 54/carriage 1008 after it has been locked over
the needle distal tip to ensure that the binding element does not
return to an orientation in which the needle pass-through feature
998 can re-engage the needle 16 and unlock the needle safety
component 56. Note that the O-ring 1002 can be employed with
needles and binding elements larger or smaller than those shown and
described herein.
[0161] The O-ring 1002 in the above embodiments is sufficiently
compliant so as to stretch over the aforementioned structures while
imparting the desired force, as explained above. In one embodiment,
the O-ring 1002 material includes any one or more of natural or
synthetic rubber, elastomers, polymers, thermoplastics, silicones,
etc. In one embodiment, the O-ring material is selected so as to
provide sufficient tear resistance, ability to impart the desired
friction, and chemical compatibility. The size of the O-ring can
vary according to the size and configuration of the binding element
and needle. In other embodiments, the O-ring can include other
shapes, materials, and positional placements while still providing
the intended functionality.
[0162] FIG. 41A shows that the guidewire lever 24 can include a
catheter advancement feature that enables the guidewire lever to
distally advance the catheter 42 in addition to advancing the
guidewire 22 as described above. In the present embodiment, the
catheter advancement feature includes an advancement tab 1014
disposed on the proximal portion 24A of the guidewire lever 24 and
disposed so as to physically engage the cap 58 of the safety
housing 54 when the guidewire lever 24 is moved distally via distal
sliding by the user of the slide 28 (FIG. 34). Such engagement is
shown in FIG. 41B. Further distal movement of the guidewire lever
24 results in distal advancement of the safety can 54 and the
catheter 42 indirectly but operably attached thereto (FIG. 34). The
slide 28 in the present embodiment can be slid to distally advance
the catheter 42 a predetermined distance via the advancement tab
1014 of the guidewire lever 24. In one embodiment, the
predetermined distance advances the catheter 42 until its distal
end distally advances over the distal tip of the needle 16. Further
distal advancement of the catheter 42 can be achieved via distal
sliding of the handle 48 as needed (FIG. 34). In another
embodiment, the slide 28 is configured to distally advance the
catheter the full distal distance needed, via the advancement tab
1014.
[0163] The position of the advancement tab 1014 of FIG. 41A is such
so as to provide staged advancement of the guidewire 22 and
catheter 42. In particular, distal advancement of the guidewire
lever 24 from the position shown in FIG. 41A produces immediate
advancement of the guidewire 22 while the safety housing 54 and
catheter 42 remain in place. Further distal advancement of the
guidewire lever 24 to the position shown in FIG. 41B causes the
advancement tab 1014 to engage and distally advance the safety can
54 and catheter 42, as described above, while continuing to
distally advance the guidewire 22.
[0164] Thus, in addition to distally advancing the guidewire 22 out
through the needle 16, the guidewire lever 24 can also advance the
catheter 42 distally along the needle 16 and into a vessel of the
patient, as described further above. Note that the particular shape
and configuration of the advancement tab 1014, together with its
manner of engagement with, and magnitude of travel imparted to, the
safety housing and/or catheter can vary from what is shown and
described herein.
[0165] FIGS. 42 and 43 depict details of the guidewire 22
configured in accordance with one embodiment. As shown in FIG. 42,
the guidewire 22 includes an elongate core wire 1102 that includes
a reduced-diameter distal portion 1104. An outer coil 1108 extends
about the core wire 1102 proximally from the distal end 1102B
thereof. A stiffening sleeve 1110 is disposed about the core wire
1102 proximal and adjacent to the coil 1108 within the
reduced-diameter distal portion 1104. The stiffening sleeve 1110
can be glued, welded, press-fit, or otherwise secured to the core
wire 1102.
[0166] The portion of the guidewire 22 on which the coil 1108 is
included is designed so as to be relatively flexible so as to
non-traumatically enter a vein or other vessel of a patient and to
guide the catheter 42 into the vein during catheter insertion using
the insert tool described herein. In contrast, the portion of the
guidewire 22 on which the stiffening sleeve 1110 is included is
relatively rigid. As seen in FIG. 43, the stiffening sleeve 1110 is
positioned so that it is disposed adjacent the distal tip 16B of
the needle 16 of the insertion tool upon full extension of the
guidewire 22 during insertion tool use. Together with the back-cut
bevel of the needle distal tip 16B, the stiffening sleeve 1110
effectively blunts the needle distal tip, thus preventing
inadvertent piercing or shearing of the catheter tube 44 by the
needle distal tip during catheter insertion into the vein. The
stiffening sleeve 1110 can be sized so as to substantially occupy
the whole of the diameter of the needle lumen at the distal tip 16B
so that it effectively prevents the needle distal tip from being
able to pierce the catheter tube 44, even if the catheter tube is
retracted while disposed over the needle, or if the needle is
re-inserted into the catheter tube. Note that, in another
embodiment, the core wire itself can be used to blunt the needle
distal tip. In one embodiment, the coil 1108 can include platinum,
stainless steel, titanium, nitinol, or other material having
suitable tensile strength and formability. In one embodiment, the
stiffening sleeve 1110 includes stainless steel, titanium,
high-rigidity thermoplastic, or other suitable material, and the
core wire 1102 includes nitinol, though other suitable materials
may be used for these and other related components.
[0167] FIG. 42 further shows that the core wire 1102 of the
guidewire 22 can include a notch 1112 disposed proximal to the
distal portion 1104 of the core wire. The notch 1112 serves as a
relative weak point for preferential breaking of the guidewire 22
at the notch should the guidewire be subjected to excessive
physical forces. By breaking at the notch 1112, the broken-off
distal segment of the guidewire is large enough as to not be
embolized into the vessel of the patient and can be readily removed
manually from the body. The particular location of the notch on the
guidewire can vary.
[0168] FIG. 44 shows that, in one embodiment, the distal end of the
catheter tube 44 of the catheter 42 of the insertion tool can
include a reinforcement component 1118 disposed substantially at
the distal end 44A of the catheter tube. As shown in FIG. 44, the
reinforcement component 1118 here includes an annular sleeve that
defines the distal end 44A of the catheter tube 44. Including a
sufficiently rigid material, such as aromatic polyurethane,
carbothane, isoplast, pebax, nylon, or other suitable medical grade
thermoplastic, metals including stainless steel, titanium, nitinol,
etc., the reinforcement component 1118 is positioned and designed
to prevent collapse of the distal end 44A of the catheter tube 44
during fluid aspiration through a lumen 1114 of the catheter tube
after the catheter 42 has been placed within the patient
vasculature. In one embodiment, the reinforcement component 1118
includes a material that is non-softening at internal body
temperature, includes a similar melt temperature to that of the
material of the catheter tube 44, and is biocompatible. In one
embodiment, the reinforcement component 1118 includes a material
having a hardness between about 60D and about 75D Shore hardness,
though other hardness ratings are possible. In another embodiment,
the reinforcement component 1118 can include a radiopacifier, such
as bismuth trioxide, barium sulfate, etc., to enhance radiopacity
of the distal end 44A of the catheter tube 44.
[0169] FIGS. 45A and 45B depict details regarding the manufacture
of the catheter tube 44 of FIG. 44, according to one embodiment,
though other techniques can be employed. As shown, during
manufacture a shaped mandrel 1120 is disposed within the lumen 1114
of the catheter tube 44. The pre-formed, annular reinforcement
component 1118 is disposed about a tip portion 1122 of the mandrel
1120 as to be interposed between the mandrel and the catheter tube
44 and substantially co-terminal with the distal end 44A thereof,
in the present embodiment. In other embodiments, the reinforcement
component 1118 can also positioned so as to produce a finished
reinforcement component position that terminates proximal to the
distal end 44A of the catheter tube 44, co-terminal therewith, or
distal thereto, so as to customize a desired reinforcement profile,
or to accommodate processing parameters, etc.
[0170] A tipping die 1124 is then paced over the distal end of the
catheter tube 44, and a radio frequency ("RF") tipping process is
carried out so as to form the distal end of the catheter tube with
the reinforcement component 1118 included therein, as shown in FIG.
44. A plug 1126 of excess material is often created as a result of
the tipping process, and can be discarded. In addition to this,
other processes can be employed to form the reinforcement structure
with the distal end of the catheter tube.
[0171] Other embodiments of reinforcement structures for the distal
end 44A of the catheter tube 44 are possible, such as the
reinforcement components 1118 shown in FIGS. 46 and 47A, for
example. FIG. 47B shows another embodiment, wherein the
reinforcement component 1118 is set back proximal to the distal end
of the catheter tube 44, thus illustrating that the reinforcement
component need not be disposed at the distal end of the catheter
tube in one embodiment. As such, these and other reinforcement
designs are therefore contemplated.
[0172] FIGS. 48A-48F depict various details of the insertion tool
10 according to another embodiment. As shown in FIG. 48A, the
insertion tool 10 includes the top and bottom housing portions 12A,
12B of the housing 12, from which extends the catheter 42 disposed
over the needle 16. Also shown is a finger pad 1218 of the
guidewire advancement assembly 20 slidably disposed in a slot 1236
defined in the top housing portion 12A, and a portion of a handle
assembly 1220 of the catheter advancement assembly 40. Further
details are given below of the present insertion tool 10 and its
various details in accordance with the present embodiment.
[0173] FIGS. 48A-48F show that the finger pad 1218 as part of the
guidewire advancement assembly 20 can be slid by a finger(s) of the
user distally along the slot 1236 in order to enable selective
advancement of the guidewire 22 (initially disposed within the
lumen of the needle 16) out past the distal end 16B of the needle
16. As before, a proximal end of the guidewire 22 is attached to an
interior portion of the top housing portion 12A such that a single
unit of distal sliding advancement of the finger pad 1218 results
in two units of distal guidewire advancement. This, as before, is
made possible by looping the guidewire 22 from its attachment point
on the top housing portion 12A and through the guide surfaces 980
included on the guidewire lever 24 (FIGS. 53A and 53B) before
extending into the lumen of the needle 16. Note that in the present
embodiment the guidewire lever 24 and finger pad 1218 of the
guidewire advancement assembly 20 are integrally formed with one
another, though they may be separately formed in other embodiments.
Note also that the guidewire 22 can be attached to other external
or internal portions of the insertion tool 10, including the bottom
housing portion 12B, the needle hub 1214, etc.
[0174] FIGS. 48A-48F further show that the catheter advancement
assembly 40 for selectively advancing the catheter 42 in a distal
direction out from the housing 12 of the insertion tool 10 includes
a handle assembly 1220, which in turn includes among other
components two wings 1280 that are grasped by the fingers of the
user when the catheter is to be advanced. As will discussed in
further detail below, the wings 1280 distally advanced via the gap
1250 defined between the top and bottom housing portions 12A,
12B.
[0175] The top and bottom housing portions 12A, 12B are mated
together via the engagement of four tabs 1230 (FIGS. 48D, 49) of
the top housing portion with four corresponding recesses 1232
located on the bottom housing portion. Of course, other mating
mechanisms and schemes can be employed for joining the top and
bottom housing portions together.
[0176] The exploded view of the insertion tool 10 in FIG. 49 shows
that the handle assembly 1220 includes a head portion 1222 from
which extend the wings 1280, and a tail portion 1224. Both the head
portion 1222 and the tail portion 1224 are removably attached to
the catheter hub 46, as will be discussed further below. Internal
components of the insertion tool 10 that are disposed within the
housing 12, each of which is passed through by the needle 16
include valve 52, the safety housing 54 in which the carriage 1008
and the needle safety component 56 is disposed, and the cap 58 of
the safety housing. The O-ring 1002 that is included with the
needle safety component 56 is also shown, as is a needle hub 1214,
which is secured to a proximal end of the needle 16 and is mounted
to the housing 12 to secure the needle 16 in place within the
insertion tool 10. Note in FIG. 49 that, in one embodiment, the
slot 1236 in which the finger pad of the guidewire advancement
assembly 20 is disposed includes a relatively wide portion to
enable the guidewire lever 24 to be inserted therethrough in order
to couple the guidewire advancement assembly to the housing 12.
[0177] FIGS. 50A and 50B depict various details regarding the
stability structure 70 for supporting and stabilizing the needle 16
at its exit point from the housing 12, according to the present
embodiment. As shown, proximal portions of the top and bottom
housing 12A, 12B inter-engage to provide the stability structure 70
for the needle 16. The bottom housing portion 12B includes two
distally-disposed arms 1248 separated by a slot 1246 that enables
the arms, when unconstrained, to separate from one another. The top
housing portion 12A defines a distal slot 1240 and a horseshoe
feature 1242 distal to the slot. Given the downward curvature of
the top housing portion 12A (see FIG. 48C), the slot 1240 enables
the arms 1248 of the bottom housing portion 12B to protrude upward
through the slot to surround and support the needle 16 in order to
stabilize it. The horseshoe feature 1242 is disposed about the
needle 16 at the distal end of the bottom housing arms 1248 and
acts as a collar to stabilize the needle.
[0178] The arms 1248 of the bottom housing portion 12B are
configured to be able to move back and forth in the x-direction,
according to the x-y axis shown in FIGS. 50A and 50B, while
remaining substantially rigid in the y-direction. Conversely, the
distal portion of the top housing portion 12A that includes the
slot 1240 and the horseshoe feature 1242 is configured so as to
flex in the y-direction according to the x-y axis shown in FIGS.
50A and 50B, while remaining substantially rigid in the
x-direction. Thus, when overlapped or inter-engaged as shown in
FIGS. 50A and 50B, the above-referenced components of the stability
structure 70 cooperate to support the needle 16 and prevent its
substantial movement when the housing 12 is in the configuration
shown in FIGS. 50A, 50B, that is, before removal of the catheter 42
from the housing 12. This in turn assists the user in accurately
piercing the skin and accessing a vessel of the patient. It is
appreciated that the stability structure can include other
components to stabilize the needle in addition to those explicitly
described herein.
[0179] FIGS. 51-54 depict various details regarding the catheter
advancement assembly 40 and the guidewire advancement assembly 20,
according to the present embodiment. As discussed, the catheter
advancement assembly 40 includes the handle assembly 1220, which in
turn includes the head portion 1222 with the corresponding wings
1280, and the tail portion 1224 disposed about a portion of the
catheter hub 46 and the safety housing 54. As will be discussed
further below, the handle assembly 1220 is employed in distally
advancing and removing the catheter 42 from the insertion tool
10.
[0180] FIGS. 51-54 further show the finger pad 1218 and the
guidewire lever 24 of the guidewire advancement assembly 20 for the
present embodiment. As shown, the guidewire lever 24 extends
proximally from the finger pad 1218 and includes on its proximal
end the previously discussed guide surfaces 980 for guiding the
looping of the guidewire 22. An actuation block 1258 is also
included near the proximal end of the guidewire lever 24 for use in
enabling catheter advancement, as will be described further below.
Note that the particular size, shape, and other configuration of
the actuation block can vary from what is shown and described
herein while retaining the desired functionality.
[0181] A spring arm 1260 extends downward from the guidewire lever
24 and is configured to be slidably retained between two guide
posts 1264 of the needle hub 1214, as best seen in FIGS. 53A and
53B. The spring arm 1260 is employed for locking further movement
of the guidewire advancement assembly 20 once the guidewire 22 has
been fully distally extended from the insertion tool 10 and the
catheter 43 advanced an incremental amount. In particular, distal
sliding by the user of the finger pad 1218 causes the guidewire
lever 24 to also distally move, which in turn distally advances the
guidewire 22 (which internally loops past the guide surfaces 980 of
the guidewire lever 24 and into the needle lumen) through the lumen
of the needle 16 and past the needle distal end 16B, as seen in
FIG. 54.
[0182] Upon full distal advancement of the finger pad 1218 and
guidewire lever 24 as seen in FIG. 54, the free end of the spring
arm 1260 is disposed just above a pocket 1266 defined between the
guide posts 1264 of the needle hub 1214, as seen in FIG. 53B.
Because of the location of the safety housing 54 proximal and
adjacent to the needle hub 1214 at this stage (the catheter 42--and
also the attached safety housing--in its initial seated position
due to it having not yet been distally advanced via distal
advancement of the catheter advancement assembly 40 as described
further below), the free end of the spring arm 1260 cannot yet seat
in the pocket 1266. Once the catheter 42 is advanced an incremental
distance distally, however, the attached safety housing 54 no
longer impedes downward movement of the spring arm 1260 and the
free end thereof seats into the pocket 1266 of the needle hub 1214.
Further distal movement of the guidewire advancement assembly 20 is
prevented by impingement of the finger pad 1218 on the distal end
of the slot 1236, while proximal movement is prevented by the
seating of the spring arm in the pocket 1266 of the needle hub.
[0183] Note that the finger pad 1218 includes on its underside
proximate its distal end a protrusion 1254 that engages with a
depression 1252 defined on the top housing portion 12A when the
finger pad is completely distally advanced. This assists in keeping
the finger pad 1218 seated in its distal position and provides a
tactile cue that the finger pad has been fully distally
advanced.
[0184] Note also that, should the catheter advancement assembly 40
be moved proximally back to its initial position (as seen in FIG.
52), the safety housing 54 will once again abut against the needle
hub 1214 and push the free end of the spring arm 1260 up and out of
the pocket 1266. This in turn enables the guidewire advancement
assembly 20 to again move proximally and distally, causing
corresponding proximal and distal advancement of the guidewire 22
itself. Thus, locking of the guidewire advancement is reversible,
in the present embodiment.
[0185] In another embodiment it is appreciated that a push button
can be included with the guidewire advancement assembly 20 to
enable the guidewire to be extended or retracted anew after locking
of the guidewire has initially occurred, such as via depressing of
the button to disengage the spring arm 1260 from the pocket 1266 of
the needle hub, for instance. These and other variations are
therefore contemplated.
[0186] FIGS. 55-56C show that, in accordance with the present
embodiment, the insertion tool 10 as presently described further
includes locking of catheter movement prior to the distal
advancement of the guidewire 22 as described above. In detail,
FIGS. 55 and 56A shows the guidewire advancement assembly 20 and
the tail portion 1224 of the handle assembly 1220 of the catheter
advancement assembly 40 in their initial positions within the
insertion tool housing 12, that is, prior to distal guidewire
advancement and catheter distal advancement. In this position, two
spring arms 1272 of the tail portion 1224 are positioned such that
both guide posts 1264 of the needle hub 1214 are seated within
respective notches 1274 of the spring arms, best seen in FIG. 56A.
In this position, the tail portion 1224 is prevented from movement.
Given the attachment of the tail portion 1224 to the hub 46 of the
catheter 42, this also prevents distal advancement of the catheter
or any other portion of the catheter advancement assembly 40.
[0187] As seen in FIGS. 56A and 56B, distal advancement of the
guidewire lever 24 causes its actuation block 1258 to engage
slanted surfaces 1276 of each spring arm 1272. As best seen in FIG.
56B, continued distal movement of the guidewire lever 24 causes the
actuation block 1258 to spread open the spring arms 1272, which
disengages the guide posts 1264 from spring arm notches 1274. The
actuation block 1258 impacts the guide posts 1264, as seen in FIG.
56B, at the point of full distal advancement of the guidewire 22
and the positioning of the free end of the spring arm 1260 of the
guidewire lever 24 just above the pocket 1266 of the needle hub
1214, as was described above in connection with FIGS. 52-54. At
this point, the spring arms 1272 of the tail portion 1224 are
disengaged from the guide posts 1264 of the needle hub 1214, and
distal catheter advancement is thus enabled, as shown by the distal
movement of the spring arms in FIG. 56C. Also, and as was described
above in connection with FIGS. 52-54, this distal catheter
advancement correspondingly distally moves the safety housing 54,
which is attached to the catheter 42. Movement of the safety
housing causes the free end of the spring arm 1260 of the distally
advanced guidewire lever 24 fall into the pocket 1266 of the needle
hub 1214, locking further movement of the guidewire 22 barring
return of the safety housing to its initial position adjacent the
needle hub.
[0188] Thus, it is seen that the configuration of the insertion
tool 10 of the present embodiment prevents distal movement of the
catheter 42 until full distal extension of the guidewire 22 has
occurred. Also, further movement of the guidewire 22 is prevented
while the catheter 42 has been distally advanced at least
incrementally from its original proximal position. In another
embodiment, an incremental amount of guidewire distal advancement
could enable catheter advancement.
[0189] In yet another embodiment, locking of guidewire movement is
made permanent after full distal advancement. This could be
achieved, in one embodiment, by configuring the spring arm 1260 of
the guidewire lever 24 and the pocket 1266 of the needle hub 1214
to not interact with the safety housing 54; as such, once the free
end of the spring arm 1260 seats within the needle hub pocket 1266,
it remains seated permanently. In another embodiment, locking of
catheter movement is made after full distal catheter advancement.
In still another embodiment, guidewire and/or catheter advancement
can be achieved via a ratcheting mechanism.
[0190] In another embodiment, the ability to advance the catheter
is unrelated to guidewire advancement. In yet another embodiment,
the spring arm 1260 of the guidewire lever 24 can be removed such
that no locking of the guidewire advancement assembly 20 occurs. In
turn, this enables locking of catheter advancement until full
distal guidewire advancement has occurred. These and other
variations are therefore contemplated.
[0191] FIGS. 57A and 57B depict various details regarding the
distal advancement of the catheter 42 from the insertion tool 10.
As shown, once the guidewire advancement assembly 20 has distally
advanced the guidewire 22 such that it extends past the distal end
16B of the needle 16, the catheter advancement assembly 40 is free
(as described above in connection with FIGS. 55-56C) to be employed
in distally advancing the catheter 42 out the distal end of the
insertion tool housing 12. The catheter 42 is advanced by a user
grasping one or both of the wings 1280 of the head portion 1222 of
the handle assembly 1220 and moving the wings distally. Note that
ridges 1282 (FIG. 50B) are included to assist the user in gripping
the wings 1280. The wings 1280 slide distally in the gap 1250
defined between the top and bottom housing portions. Given the
attachment of the wings 1280 to the head portion 1222, which in
turn is attached to the hub 46 of the catheter 42, distal sliding
of the wings distally advances the catheter.
[0192] FIGS. 57A and 57B show that, as the catheter 42 is distally
advanced, the distal movement of the wings 1280 causes the wings to
impinge on and push upwards the top housing portion 12A, which in
turn lifts the distal portion of the top housing portion, including
the slot 1240 and the horseshoe feature 1242 of the stability
structure 70. Lifting of the slot 1240 causes the arms 1248 of the
bottom housing portion 12B to disengage from the slot, thus
enabling them to spread apart. FIGS. 57A and 57B show that two
posts 1286 disposed on the head portion 1222 of the handle assembly
1220 (see also FIG. 60) push against each of the arms 1248 as the
catheter distally advances, which causes the arms to separate. This
separation of the arms 1248, together with the lifting by the wings
1280 of the top housing portion, enables the catheter 42 to pass
through the distal end of the housing 12.
[0193] FIGS. 58 and 59 show removal of the catheter 42 and catheter
advancement assembly 40 from the insertion tool housing 12, wherein
continued distal advancement of the head portion 1222 via the user
grasping and advancing the wings 1280 causes the catheter 42, the
handle assembly 1220 (including the head portion 1222 and the tail
portion 1224), and the safety housing 54 removably attached to the
catheter hub 46 to slide distally along the needle 16 and out of
the housing 12. This action is performed, for instance, to advance
the catheter tube 44 into the vessel of the patient after the
needle 16 and the guidewire 22 have cooperated to provide a pathway
into the vessel.
[0194] FIG. 59 shows that further separation of the catheter 42 and
handle assembly 1220 from the housing 12 causes the safety housing
54 to arrive at the distal end 16B of the needle 16, at which point
the needle safety component 56 disposed in the safety housing (FIG.
49) engages the needle distal tip to prevent accidental needle
sticks for the user, and the safety housing laterally detaches from
the catheter hub 46 and remains with the needle.
[0195] FIG. 60 shows various features of the handle assembly 1220,
which includes the head portion 1222 and the tail portion 1224.
After the above separation of the safety housing 54 and needle 16
from the catheter 42 and handle assembly 1220, the head portion
1222 and the tail portion 1224 remain attached to the needle hub 46
and its corresponding strain relief 47 via clip arms 1300 and 1304,
respectively. At this point, the head portion 1222 can be removed
from the catheter hub 46/strain relief 47 by the hand of the user
to overcome the friction fit of the clip arms 1300. The tail
portion 1224, which includes a loop 1306 disposed about the valve
52, can also be removed via pulling and twisting by the user to
overcome the friction fit of the clip arms 1304 and avoid the
threads of the catheter hub 46. This action will remove the valve
52 (see FIG. 49), which is attached to the tail portion 1224. In
another embodiment, the tail portion loop 1306 is configured so
that the valve 52 is exposed after removal of the tail portion 1224
so as to enable removal of the valve by the user when desired. Once
the head portion 1222 and the tail portion 1224 of the handle
assembly 1220 have been removed from the catheter 42, the catheter
can be dressed and used as desired.
[0196] The handle assembly 1220 can be configured in other ways, in
addition to what has been described above. FIGS. 61 and 62 give one
example of the handle assembly 1220, wherein the head portion and
the tail portion are unified in a singular body 1312. As shown in
FIG. 62, this enables the safety housing 54 to be removed laterally
from the handle assembly 1220, after which the catheter hub 46 can
be removed vertically therefrom. FIG. 63 includes a similar
configuration for the handle assembly 1220, wherein the valve 52
includes oppositely-disposed extensions 1316, which enables the
extensions to be gripped (after lateral removal of the safety
housing 54) and the handle assembly 1220 is removed vertically.
These actions leave the valve 52 and its extensions 1316 attached
to the hub 46 of the catheter 42, at which point the valve can be
removed from the hub laterally, using the extensions if
desired.
[0197] In FIG. 64, the handle assembly 1220 includes a singular
body that defines a living hinge 1320 disposed just distal to the
loop 1306, though other locations for the living hinge are
possible. Note that the loop 1306 captures the valve 52. In one
embodiment, the valve 52 is integrally formed with or attached to
the handle assembly body. In another embodiment, the valve 52 is
separate from the handle assembly 1220 and is not affected by
removal of the handle assembly 1220. The handle assembly 1220
further includes the clip arms 1304 that removably attach to the
catheter hub 46 to secure the catheter 42 in place. Posts 1286 are
also included on the handle assembly 1220, as in previous
embodiments.
[0198] As FIG. 65 shows, the wings 1280 can be grasped to arcuately
pull the distal portion of the handle assembly 1220 proximally,
which then disengages the clip arms 1304 and posts 1286 from the
catheter hub 46 and enables the handle assembly and valve 52 to be
pulled from the catheter hub laterally. These and other handle
assembly configurations are therefore contemplated.
[0199] FIGS. 66A-66C depict details of an insertion tool including
a catheter advancement configuration according to one embodiment,
wherein an insertion tool housing 1340 includes a catheter
advancement lever 1344 that engages with a guidewire advance button
such that the catheter advancement lever is initially maintained in
a depressed position underneath the guidewire advance button,
preventing catheter advancement. Once the guidewire advance button
1348 is moved distally, the catheter advancement lever 1344 pops
upward, which unlocks catheter advancement and enables the catheter
tube 44 to be distally advanced, such as by distal movement of the
catheter advancement lever. It is appreciated that one or more of a
variety of internal mechanisms can be included in the housing 1340
to facilitate the functionality described here.
[0200] Note that the insertion tool 10 as described immediately
above is configured so that it can be grasped by a hand of the user
and employed in deploying the catheter into the patient without the
need for the user to move the hand grasping the device. In
particular, the finger pad 1218 of the guidewire advancement
assembly 20 and the wings 1280 of the catheter advancement assembly
40 are positioned distal relative to the location where the user
grasps the housing 12 in order to use the insertion tool 10, thus
eliminating the need for the user to move the grasping hand during
advancement of the finger pad or wings.
[0201] In one embodiment, the user grasps the insertion tool
housing 12 with one hand and uses the other hand to advance at
least one of the finger pad 1218 and the wings 1280, again without
moving the hand grasping the insertion tool housing. In another
embodiment, the user can use the fingers of the hand grasping the
insertion tool housing to advance one or both of the finger pad
1218 and the wings 1280.
[0202] Embodiments of the invention may be embodied in other
specific forms without departing from the spirit of the present
disclosure. The described embodiments are to be considered in all
respects only as illustrative, not restrictive. The scope of the
embodiments is, therefore, indicated by the appended claims rather
than by the foregoing description. All changes that come within the
meaning and range of equivalency of the claims are to be embraced
within their scope.
* * * * *